The gum resin of Boswellia has been very widely used since ancient times. For example, the gum resin of Boswellia serrata (Burseraceae) has long been in use for the treatment of rheumatoid arthritis and gout by the practitioners of Ayurvedic medicines in the Indian system of medicine. Various extracts of the gum resin have shown potent anti-inflammatory and anti-atherogenic activity in laboratory animals. The extract of Boswellia was found to be a potent anti-arthritic agent. Boswellia gum resin and its extracts also demonstrated significant therapeutic improvements inhuman clinical trials thus confirming the in vivo anti-inflammatory effects.
The origin of the anti-inflammatory action of Boswellia gum resin and its extracts has been attributed to a group of triterpene acids called Boswellic acids that were isolated from the gum resin of Boswellia serrata. Boswellic acids exert anti-inflammatory actions by inhibiting 5-lipoxygenase (5-LOX). 5-LOX is a key enzyme for the biosynthesis of leukotrienes from arachidonic acid. Leukotrienes are considered to be involved in the initiation and propagation of a variety of inflammatory diseases. In addition to their 5-lipoxygenase inhibition, Boswellic acids inhibit human leukocyte elastase (HLE), an enzyme of different pro-inflammatory pathway. 3-O-Acetyl-11-keto-β-Boswellic acid (AKBA) is biologically the most active component among its congeners, with an IC50 of 1.5 μM for the inhibition of 5-LOX.
The U.S. Pat. Nos. 5,716,928 and 5,665,386 relate to a method for increasing bioavailability of an orally administered hydrophobic pharmaceutical compound, which comprises orally administering the pharmaceutical compound to a mammal in need of treatment with the compound concurrently with an essential oil or essential oil component in an amount sufficient to enhance bioavailability of the compound. Specifically, bioavailability of the compound in the presence of the essential oil or essential oil component is greater than bioavailability of the compound in the absence of the essential oil or essential oil component. The essential oil or essential oil component has an activity of at least 10% inhibition at a concentration of 0.01 wt. % or less, in an assay that measures reduced conversion of cyclosporine to hydroxylated products using an assay system containing 250 μg rat liver microsomes, 1 μM cyclosporine and 1 mM reduced nicotinamide adenine dinucleotide phosphate (NADPH) in 1 ml of 0.1 M sodium phosphate buffer, pH 7.4.
PCT publication WO 02/15916 discloses dihydro Boswellia acids, physiologically acceptable salts thereof and hydrogenated extracts from Boswellia. These compounds are useful for the prophylactic and/or therapeutic treatment of undesired physical and psychic conditions, in particular of somatic, psychosomatic and psychic diseases, such as inflammatory processes caused by increased leukotriene formation, leukocyte elastase or plasmin activity.
There is, however, no prior art, to the best of inventors knowledge, relating to the use of non-acidic Boswellia gum resin extract fractions for increasing the bioavailability of biological agents in warm blooded animals.
Approximately 30 percent of older Americans do not get the dietary requirements of all the essential nutrients. The hazards of food-drug interactions in depleting essential nutrients are well recognized. It is unavoidable that old age calls for increased use of medications. For example, use of certain antibiotics decreases absorption of calcium and iron, while EDTA chelation therapy decreases absorption of zinc, iron, copper, and magnesium.
In addition, many foods which increase the risk of cancer and cardiovascular disease have to be eliminated from the diet, which further depletes the sources of essential nutrients. For example, excellent sources of vitamin B and vitamin D, such as red meat, liver, egg yolk, cheese and dairy products, are often limited because of their high cholesterol content.
Limited menu also causes a depletion of essential amino acids, such as tryptophan, which is important precursor of neurotransmitters, and may play a role in the prevention of brain deterioration with aging. The availability of essential nutrients is further compromised by poor gastrointestinal absorption.
The traditional way to offset insufficient nutrient supplementation, insufficient gastrointestinal absorption and insufficient metabolic utilization of essential nutrients is to administer large doses of compensating materials, such as vitamin and mineral supplements.
Hence, there exists a great need for the development of a compound/composition which helps in increasing the availability of biological agents through one or more mechanisms comprising increasing the bioavailability, increasing the serum concentration, improving gastrointestinal absorption, improving systemic utilization, improving cross over through certain biological barriers such as respiratory lining, urinary lining, blood brain barrier and skin in warm blooded animals.